Otsuka re-submits marketing application for digital drug

On May 23rd Otsuka Pharmaceutical Co Ltd re-filed a marketing application for its digital medicine with the US Food and Drug Administration (FDA). The drug-device combination is intended to be used to treat patients with mental disorders and as an additional treatment for major depression.

The FDA had previous rejected the product in April 2016 and had requested additional information related to its performance under specific medical conditions. The company was also asked to furnish data on any risk factors associated with the product while confirming its safety.

In its treatment, the digital medicine combines Otsuka's FDA-approved tablet Abilify (aripiprazole), used to treat schizophrenia and bipolar disorder, with an ingestible sensor made by Proteus Digital Health. The sensor records information related to medicine intake and communicates it to the patient through a wearable sensor patch. While the sensor is already approved for use with other drugs, this was the first time it was embedded within the tablet itself.

The company expects the FDA to take a decision on the latest marketing application in the fourth quarter of 2017. With this digital medicine, Otsuka is targeting an untapped market for products to help mentally ill patients manage their daily medication. Abilify, which was approved in 2002, is also being reviewed for an additional indication of autism.